Hymenoptera Venom Immunotherapy: Evaluation of Its Long-term Efficacy at the University Hospital of Angers (EFLOTITA2)

NCT05311644 | Completed DMC

• 1 other identifier: 49RC20_0158
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

Allergy to Hymenoptera venom is one of the main causes of anaphylaxis in adults, and is less common in the paediatric population. It can be severe or even fatal. Despite the use of an emergency kit, including an adrenaline auto-injector (AAI), at present only hymenoptera venom immunotherapy (VIT) is effective in preventing subsequent severe systemic reactions. Recurrence during the 5 years following cessation of VIT is about 10-15 percent. Studies evaluating longer-term efficacy are scarce. At the University Hospital of Angers, hundreds of patients are treated each year, and its allergology unit has been providing VIT for over 15 years. The purpose of this stufy is to evaluate VIT efficacy among patients who were treated with VIT and ceased VIT from 2005 to 2019, at the university hospital of Angers.

Conditions

Anaphylaxis Caused by Hymenoptera Venom (Disorder)

Keywords

hymenoptera venom immunotherapy; anaphylaxis; venom allergy

Outcome Measures

Primary Outcomes (1)

• Reccurence of a systemic reaction

  The recurrence of a systemic reaction after a hymenoptera sting reported by the patient during the telephone survey.

  up to 17 years since the patient ceased hymenoptera venom immunotherapy.

Secondary Outcomes (2)

• To describe the evolution of the results of the allergy work-up during hymenoptera venom immunotherapy

  up to 17 years since the patient ceased hymenoptera venom immunotherapy to the last appointement in the allergy unit.

• Predicting the recurrence of systemic symptoms

  up to 17 years since the patient ceased hymenoptera venom immunotherapy until the phone survey

Study Arms (1)

Included

All participants that cesed VIT between 2005 and 2019, and did not withdraw his consent to participate to the study.

Other: Telephone survey

Interventions

Telephone survey OTHER

All participants are interviewed by telephone, and are asked to answer a survey.

Included

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Allergy to hymenoptera venom, Treated with VIT at the university hospital of Angers, Ceased VIT between 2005 and 2019

You may qualify if:

• Allergy to hymenoptera venom.
• Treated with VIT at the university hospital of Angers.
• Ceased VIT between 2005 and 2019.

You may not qualify if:

• Patient's opposition, or the Participant's legal guardian's, if minor, to participate to the study, and/or for his data to be used.

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

University hospital of Angers

Angers, Maine et Loire, 49100, France

Location

MeSH Terms

Conditions

Anaphylaxis; Venom Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: April 5, 2022
• Study Start: April 14, 2022
• Primary Completion: March 14, 2024
• Study Completion: March 14, 2024
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)